Field of the Invention
The invention relates to a sterile packaging unit containing a suture threader and a suture anchor for easy application of a suture to the anchor and a method for using the cartridge.
Description of the Background Art
The field of arthroscopy has advanced quickly in recent years, demanding quicker, easier and minimally invasive techniques for increasingly common joint surgeries. Since speed and efficiency translate into quicker recover times and overall better patient experiences, saving time and avoiding mistakes greatly improves operating success.
Soft tissue, such as a tendon or ligament, can rupture and become damaged or detached from a patient's bone as a result of injury or a medical procedure. Injuries of this type include, torn rotator cuffs, labral tears, bicep tendon tears and quadricep ruptures. Surgical treatment of a torn rotator, for example, is designed to reattach the damaged tendon(s) back to the humeral head (ball of the shoulder joint) from which it was torn. Other torn tendons and ligaments require similar procedures.
Bone anchors are one medical implant than can be used to attach soft-tissue to the bone. These anchors are designed to hold the tissue onto the bone at its point of reattachment to allow the tissue to heal and naturally reattach itself to the bone. Alternatively, sutures may be threaded through the soft tissue and tied to an anchor implanted in the bone.
Two points in a normal operation procedure present difficulty and are prone to mistakes. The first is knotting the suture onto the suture anchor or alternatively threading the suture through an eyelet in the anchor. The second is keeping the driver and suture threads in-place and connected to the anchor while adjusting the suture and implanting the anchor in the bone.
After threading the suture through the tendon or ligament to be reattached, the surgeon must tie the suture off to the anchor before inserting the anchor into the bone. Bone anchors are tiny and the holes or mounts to which the suture is tied are even smaller. Therefore, tying the suture off requires extreme dexterity and hand-eye coordination on the part of the surgeon.
One prior art device for aiding the surgeon is disclosed in U.S. Pat. No. 5,741,300 and provides a surface for holding the suture anchor and a threading loop for assisting the surgeon in threading and knotting the suture. The disclosed process, however, still requires threading the loop and knotting the suture to the anchor to prepare the anchor for implantation. Furthermore, the anchor itself is not securely fastened to the holder but simply held by gravity, thus providing the surgeon with little stability beyond the larger holding area.
Knotless suture anchors have been introduced but these present their own difficulties. To provide knotless fastening of the suture, suitable locking bridges are needed between the outer face of the body of the anchor element and the inner face of the sleeve. These make release from this locked position difficult or impossible. Additionally, locking the suture into the anchor requires clamping that can damage the suture by the shearing of the inner screw against the sleeve.
Thus, the prior art devices remain difficult to use and prone to mistakes and damage. The invention described below offers several features to increase usability and efficiency as well as guarantee the safe implantation of the device in the patient. The benefits of these improvements include faster and cleaner surgeries as well as reductions in risk and device malfunction.